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Ajouter le résultat dans votre panier Affiner la rechercheFixed‐dose combinations of drugs versus single‐drug formulations for treating pulmonary tuberculosis / Carmen R. Gallardo (2016)
Titre : Fixed‐dose combinations of drugs versus single‐drug formulations for treating pulmonary tuberculosis Type de document : document électronique Auteurs : Carmen R. Gallardo, Auteur ; David Rigau Comas, Auteur ; Angélica Valderrama Rodriguez, Auteur Editeur : The Cochrane Collaboration Année de publication : 2016 Collection : Cochrane Database of Systematic Reviews Importance : 146 p. Présentation : ill. ; tab. ; graph. Langues : Anglais (eng) Catégories : [TUBER] étude:recherche:recherche clinique:essai clinique randomisé
[TUBER] traitement:traitement curatif
[TUBER] type de tuberculose:tuberculose-maladie:tuberculose pulmonaireIndex. décimale : TU 8.2. Traitement curatif Résumé : Background
People who are newly diagnosed with pulmonary tuberculosis (TB) typically receive a standard first‐line treatment regimen that consists of two months of isoniazid, rifampicin, pyrazinamide, and ethambutol followed by four months of isoniazid and rifampicin. Fixed‐dose combinations (FDCs) of these drugs are widely recommended.
Objectives
To compare the efficacy, safety, and acceptability of anti‐tuberculosis regimens given as fixed‐dose combinations compared to single‐drug formulations for treating people with newly diagnosed pulmonary tuberculosis.
En ligne : https://doi.org/10.1002/14651858.CD009913.pub2 Format de la ressource électronique : Article en ligne Permalink : https://biblio.fares.be/opac_css/index.php?lvl=notice_display&id=10154 Aucun avis, veuillez vous identifier pour ajouter le vôtre !
Titre : High-dose rifampicin, moxifloxacin, and SQ109 for treating tuberculosis : a multi-arm, multi-stage randomised controlled trial Type de document : document électronique Auteurs : Martin J. Boeree, Auteur ; Norbert Heinrich, Auteur ; Rob Aarnoutse, Auteur Editeur : Lancet Année de publication : 2017 Collection : The Lancet Infectious diseases, ISSN 1473-3099 num. 17 Importance : p. 39-49 Présentation : ill. ; tab. ; graph. Langues : Anglais (eng) Catégories : [TUBER] étude:recherche:recherche clinique:essai clinique randomisé
[TUBER] traitement:traitement curatif
[TUBER] type de tuberculose:tuberculose-maladie:tuberculose pulmonaireIndex. décimale : TU 8.2. Traitement curatif Résumé : Background: Tuberculosis is the world’s leading infectious disease killer. We aimed to identify shorter, safer drug regimens for the treatment of tuberculosis.
Methods: We did a randomised controlled, open-label trial with a multi-arm, multi-stage design. The trial was done in seven sites in South Africa and Tanzania, including hospitals, health centres, and clinical trial centres. Patients with newly diagnosed, rifampicin-sensitive, previously untreated pulmonary tuberculosis were randomly assigned in a 1:1:1:1:2 ratio to receive (all orally) either 35 mg/kg rifampicin per day with 15–20 mg/kg ethambutol, 20 mg/kg rifampicin per day with 400 mg moxifl oxacin, 20 mg/kg rifampicin per day with 300 mg SQ109, 10 mg/kg rifampicin per day with 300 mg SQ109, or a daily standard control regimen (10 mg/kg rifampicin, 5 mg/kg isoniazid, 25 mg/kg pyrazinamide, and 15–20 mg/kg ethambutol). Experimental treatments were given with oral 5 mg/kg isoniazid and 25 mg/kg pyrazinamide per day for 12 weeks, followed by 14 weeks of 5 mg/kg isoniazid and 10 mg/kg rifampicin per day. Because of the orange discoloration of body fluids with higher doses of rifampicin it was not possible to mask patients and clinicians to treatment allocation. The primary endpoint was time to culture conversion in liquid media within 12 weeks. Patients without evidence of rifampicin resistance on phenotypic test who took at least one dose of study treatment and had one positive culture on liquid or solid media before or within the fi rst 2 weeks of treatment were included in the primary analysis (modified intention to treat). Time-to-event data were analysed using a Cox proportional-hazards regression model and adjusted for minimisation variables. The proportional hazard assumption was tested using Schoelfeld residuals, with threshold p<0·05 for non-proportionality. The trial is registered with ClinicalTrials.gov (NCT01785186).
Findings: Between May 7, 2013, and March 25, 2014, we enrolled and randomly assigned 365 patients to diff erent treatment arms (63 to rifampicin 35 mg/kg, isoniazid, pyrazinamide, and ethambutol; 59 to rifampicin 10 mg/kg, isoniazid, pyrazinamide, SQ109; 57 to rifampicin 20 mg/kg, isoniazid, pyrazinamide, and SQ109; 63 to rifampicin 10 mg/kg, isoniazid, pyrazinamide, and moxifl oxacin; and 123 to the control arm). Recruitment was stopped early in the arms containing SQ109 since prespecifi ed effi cacy thresholds were not met at the planned interim analysis. Time to stable culture conversion in liquid media was faster in the 35 mg/kg rifampicin group than in the control group (median 48 days vs 62 days, adjusted hazard ratio 1·78; 95% CI 1·22–2·58, p=0·003), but not in other experimental arms. There was no diff erence in any of the groups in time to culture conversion on solid media. 11 patients had treatment failure or recurrent disease during post-treatment follow-up: one in the 35 mg/kg rifampicin arm and none in the moxifl oxacin arm. 45 (12%) of 365 patients reported grade 3–5 adverse events, with similar proportions in each arm.
Interpretation: A dose of 35 mg/kg rifampicin was safe, reduced the time to culture conversion in liquid media, and could be a promising component of future, shorter regimens. Our adaptive trial design was successfully implemented in a multi-centre, high tuberculosis burden setting, and could speed regimen development at reduced cost.
Funding: The study was funded by the European and Developing Countries Clinical Trials partnership (EDCTP), the German Ministry for Education and Research (BmBF), and the Medical Research Council UK (MRC).En ligne : http://dx.doi.org/10.1016/ S1473-3099(16)30274-2 Format de la ressource électronique : Article en ligne Permalink : https://biblio.fares.be/opac_css/index.php?lvl=notice_display&id=10863 Aucun avis, veuillez vous identifier pour ajouter le vôtre !
Titre : Safety and efficacy of the C-Tb skin test to diagnose Mycobacterium tuberculosis infection, compared with an interferon γ release assay and the tuberculin skin test : a phase 3, double-blind, randomised, controlled trial Type de document : document électronique Auteurs : Morten Ruhwald, Auteur ; Henrik Aggerbeck, Auteur ; Rafael Vázquez Gallardo, Auteur Editeur : Lancet Année de publication : 2017 Collection : The Lancet Respiratory Medicine, ISSN 2213-2600 num. 5 Importance : p. 259-68 Présentation : ill. ; tab. ; graph. Langues : Anglais (eng) Catégories : [TUBER] dépistage
[TUBER] dépistage:test tuberculinique
[TUBER] étude:recherche:recherche clinique:essai clinique randomisé
[TUBER] traitement:traitement curatif
[TUBER] type de tuberculose:tuberculose-maladie:tuberculose pulmonaireIndex. décimale : TU 6. Méthodes de dépistage Résumé : Background
Targeted screening and treatment of Mycobacterium tuberculosis infection substantially reduces the risk of developing active tuberculosis. C-Tb (Statens Serum Institute, Copenhagen, Denmark) is a novel specific skin test based on ESAT-6 and CFP10 antigens. We investigated the safety and diagnostic potential of C-Tb compared with established tests in the contact-tracing setting.
Methods
Negative controls, close contacts, occasional contacts, and patients with active pulmonary tuberculosis were enrolled at 13 centres in Spain. We compared C-Tb with the QuantiFERON-TB Gold In-Tube ([QFT] Qiagen, Hilden, Germany) interferon γ release assay (IGRA) and the purified protein derivative (PPD) RT 23 tuberculin skin test ([TST] Statens Serum Institute). All participants older than 5 years were tested with QFT. Some participants in the negative control group received C-Tb without the TST to test for potential interactions between C-Tb and PPD RT 23. The rest were randomly assigned in blocks of ten and tested with both C-Tb and TST, with five in each block receiving injection of C-Tb in the right arm and the TST in the left arm and five vice versa. The primary and safety analyses were done in all participants randomly assigned to a group who received any test. This trial is registered with ClinicalTrials.gov, number NCT01631266, and with EudraCT, number 2011-005617-36.
Findings
From July 24, 2012, to Oct 2, 2014, 979 participants were enrolled, of whom 263 were negative controls, 299 were occasional contacts, 316 were close contacts, and 101 were patients with tuberculosis. 970 (99%) participants completed the trial. Induration sizes were similar for C-Tb and TST, but TST positivity was affected by BCG vaccination status. We found a strong positive trend towards C-Tb test positivity with increasing risk of infection, from 3% in negative controls to 16% in occasional contacts, to 43% in close contacts. C-Tb and QFT results were concordant in 785 (94%) of 834 participants aged 5 years and older, and results did not differ significantly between exposure groups. The safety profile of C-Tb was similar to that for the TST.
Interpretation
C-Tb delivered IGRA-like results in a field-friendly format. Being unaffected by BCG vaccination status, the C-Tb skin test might provide more accurate treatment guidance in settings where the TST is commonly used.
Funding
Statens Serum Institut.En ligne : http://dx.doi.org/10.1016/ S2213-2600(16)30436-2 Format de la ressource électronique : Article en ligne Permalink : https://biblio.fares.be/opac_css/index.php?lvl=notice_display&id=10872 Aucun avis, veuillez vous identifier pour ajouter le vôtre !
